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Clinical trial

A Randomized Phase II Study to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan Versus CDK4/6 Inhibitor-based Endocrine Therapy as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype According to Gene Expression Profiling.

NCT06486883 is registered in ClinicalTrials.gov with MedSIR as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized Phase II Study to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan Versus CDK4/6 Inhibitor-based Endocrine Therapy as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype According to Gene Expression Profiling.
Lead sponsor
MedSIR
Phase
Phase 2
Overall status
Recruiting
Start date
June 30, 2025
Completion date
January 31, 2028
Enrollment
200 (estimated)
Sites
79

Conditions

As the registry lists them; a condition with its own page is linked.

advanced breast cancer, advanced breast carcinoma, hormone receptor positive breast carcinoma